Job Description
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide an outstanding opportunity for us all, both professionally and personally.
Join us as a Founder of our new Sandoz!
Major Accountability
Define and lead all aspects of long term strategy to ensure that Sandoz maintains its world class leading position in automated signal detection and evaluation.
Lead and manage a team of external service providers who are accountable for detecting and analyzing technical signals from post- marketing surveillance in the signal management tool for all Sandoz products, Sandoz group companies or Sandoz partners (for which an agreement is in place) where Sandoz is the global safety database holder.
Coordinate and ensure maintenance of all Sandoz MedDRA Queries which are used by the entire Sandoz organization.
Develops new approaches (including policy, methodology, process improvements) for signal detection in Safety Signal databases.
Core member of the Safety management team to provide expert input into Safety
Evaluations presented at the Safety Management Team.
Drives the development and implementation of efficient workflow processes for the Signal Management Team, the update of Business Guidance Documents and SOPs accordingly.
Brings strong scientific and medical safety leadership to oversee all signal detection activities that are performed by the Safety Signal Management team using internal and external databases, ensuring industry standard methodologies and alignment with regulatory guidance.
Ensure that all new relevant medical safety signals originating from signal review or
analyses from external Health Authority databases are adequately communicated to the respective Safety Lead for further issue to the SMT
B.Se in Pharmacy / Bachelor of Science in Nursing /PharmD / PhD or Masters in relevant field or Medical Degree (MBBS or MD) required. Post
Graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent) preferred.
- At least 8 years in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics, post marketing in a major pharmaceutical company, including 2 years in signal detection and management (or equivalent experience) is desirable.
- Proven ability to analyze, interpret, discuss, and present safety information both in writing and orally. Experience in preparation of clinical safety. assessments and regulatory reports involving safety information.
- Experience in MedDRA and post marketing safety signal detection. Experience with (safety or others) issue management and decision making on safety topics.
- Excellent written and verbal communication skills
Shown administrative skills including the ability to set and achieve goals and develop departmental strategies Experience with PV audits and inspections and writing and implementation of CAPA.
Why Sandoz
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit are powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
